Sunday, January 16, 2022 1:57:02 PM
Try harder, but thanks for another reference. I will have to dig into this one a bit. But even with limited information, this is suggesting both safety and ethics issue.
Changing the endpoints may well make the trial no longer being suitable for enrolling patients to be randomized. If the trial can no longer reasonably be expected to answer the question being posed, it is not ethical to put patients at risk.
This was the case with CVM with a similar partial hold on new patient recruitment (that was later lifted when CVM submitted a change to end enrollment).
Second, CMC issues would almost certainly be safety.
Changing the endpoints may well make the trial no longer being suitable for enrolling patients to be randomized. If the trial can no longer reasonably be expected to answer the question being posed, it is not ethical to put patients at risk.
This was the case with CVM with a similar partial hold on new patient recruitment (that was later lifted when CVM submitted a change to end enrollment).
Second, CMC issues would almost certainly be safety.
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